MyMenoPlan: Online Resource for Improving Women's Menopause Knowledge and Informed Decision-making

March 31, 2022 updated by: Andrea Z. LaCroix, PhD, University of California, San Diego

MsFLASH: Living a Healthy Menopause, Aim 2 Randomized Controlled Trial of MyMenoPlan

As part of a National Institute on Aging -funded R01, the investigators developed an evidence-based, multi-media digital resource entitled MyMenoPlan to help women learn about the menopause transition, and the symptoms and treatments of perimenopause/menopause. MyMenoPlan is also designed to help women learn about the effectiveness of treatments for a comprehensive list of midlife symptoms and compare treatments that may help with the specific symptoms women are experiencing.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The purpose of this research study is to:

  1. Investigate how women randomly assigned to visit MyMenoPlan use the website (time spent on website, treatment and symptom page views, use of interactive tools, and use of the MyMenoPlan tool).
  2. Compare the ratings of women randomly assigned to MyMenoPlan to those randomly assigned to other menopause websites for perceived quality of information, readability, self-efficacy, and credibility of these online menopause resources.

Study Type

Interventional

Enrollment (Anticipated)

410

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92037
        • UC San Diego

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • As stated above

Exclusion Criteria:

  • N/A

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: MyMenoPlan
Participants are asked to spend at least 20 minutes on the website (MyMenoPlan) assigned to them.
Other: MyMenoPlan
Participants are asked to spend at least 20 minutes on the website (MyMenoPlan) assigned to them.
ACTIVE_COMPARATOR: Control

Participants are asked to spend at least 20 minutes on at least one of the following websites or other websites of their choice:

  1. North American Menopause Society: https://www.menopause.org/for-women
  2. National Institute on Aging: https://www.nia.nih.gov/health/topics/menopause
  3. The Office on Women's Health-Menopause: https://www.womenshealth.gov/menopause
Other: Control

Participants are asked to spend at least 20 minutes on at least one of the following websites:

  1. North American Menopause Society: https://www.menopause.org/for-women
  2. National Institute on Aging: https://www.nia.nih.gov/health/topics/menopause
  3. The Office on Women's Health-Menopause: https://www.womenshealth.gov/menopause

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceived Quality of Information
Time Frame: Each survey question is answered after spending at least 20 minutes on the assigned website(s)

This 7-item, 5-point Likert scale (1- Strongly disagree to 5 - Strongly agree) is adapted from the Post-Study System Usability Questionnaire (PSSUQ) in Lewis (1995).

Items:

  1. Reading the information made me feel in more control of my perimenopause/menopause.
  2. The information on the website(s) was helpful to me.
  3. I found the information I was looking for.
  4. The information answered my questions about perimenopause/menopause.
  5. I liked the website (s).
  6. I would have liked more in-depth information. (reverse-coded)
  7. The website(s) were fairly comprehensive about perimenopause /menopause.
Each survey question is answered after spending at least 20 minutes on the assigned website(s)
Readability
Time Frame: Each survey question is answered after spending at least 20 minutes on the assigned website(s)

This 2-item, 5-point Likert (1- Strongly disagree to 5 - Strongly agree)scale was derived from the Standardized User Experience Percentile Rank Questionnaire (SUPR-Q) in Sauro (1995).

Items:

  1. The information I read was clear.
  2. The information I read was easy for me to understand.
Each survey question is answered after spending at least 20 minutes on the assigned website(s)
Self-Efficacy for Managing Menopause Symptoms
Time Frame: Each survey question is answered after spending at least 20 minutes on the assigned website(s)

This is a newly developed Likert scale (1- Strongly disagree to 5 - Strongly agree) for assessing participants' beliefs in their own abilities in managing menopausal symptoms.

Items:

  1. If I want to, I am certain I could figure out the treatments or coping strategies that would work best for me.
  2. I feel I could treat or cope with my symptoms of perimenopause/menopause if I want to.
Each survey question is answered after spending at least 20 minutes on the assigned website(s)
Credibility
Time Frame: Each survey question is answered after spending at least 20 minutes on the assigned website(s)

This 2-item, 5-point Likert (1- Strongly disagree to 5 - Strongly agree) scale was derived from the Standardized User Experience Percentile Rank Questionnaire (SUPR-Q) in Sauro (1995).

Items:

  1. The information is credible.
  2. The information is trustworthy.
Each survey question is answered after spending at least 20 minutes on the assigned website(s)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Investigators

  • Principal Investigator: Andrea Z. LaCroix, PhD, University of California, San Diego

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 15, 2022

Primary Completion (ANTICIPATED)

March 31, 2022

Study Completion (ANTICIPATED)

March 31, 2022

Study Registration Dates

First Submitted

March 1, 2022

First Submitted That Met QC Criteria

March 17, 2022

First Posted (ACTUAL)

March 29, 2022

Study Record Updates

Last Update Posted (ACTUAL)

April 8, 2022

Last Update Submitted That Met QC Criteria

March 31, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 140604

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Menopause

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hungary

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe